Regulation of Clinical Trials

Contents 1. Regulation of clinical trials in India an introduction. 2. Revised schedule Y of drugs and cosmetics rules. 3. Rule 122 of Drugs and Cosmetics Act. 4. Application format for undertaking clinical trial in India. 5. Format for fees submission. 6. Conditions for import of drugs for examination test or analysis. 7. Conditions for manufacture of drugs for examination test or analysis. 8. Stocking of drugs. 9. Indian GCP Guidelines. 10. Guidelines for bioavailability and bioequivalence studies. 11. ICH Harmonized Tripartite Guideline Guideline for good clinical practice E6(R1). 12. Data Safety Monitoring Board. 13. Registrations of clinical trials. 14. The Nuremberg Code. 15. The Belmont Report ethical principles and guidelines for the protection of human subjects of research. 16. Clinical research organisations in India. This book on Regulation of Clinical Trials is a valuable compilation of benchmark national and international guidelines and statements relating to clinical research along with original chapters written by the author. The book also deals with various provisions of Drugs and Cosmetics Act and Rules thereunder which lays down conditions and requirements for the conduct of clinical trials in India. Various important topics like Data Safety Monitoring Board and Registrations of Clinical Trials have been incorporated. 350 pp.…